Bulk-Fill Composite Restorations: Clinical Evaluation

April 7, 2026 updated by: Cemile Arslan, Ataturk University

Clinical Evaluation of Restorations Performed With Bulk-Fill Composites of Different Technologies According to FDI Criteria: A Randomized Controlled Clinical Follow-Up Study

This randomized controlled clinical study aims to evaluate the clinical performance of five different bulk-fill composite materials representing distinct technological approaches according to the World Dental Federation (FDI) criteria. The materials include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER-based bulk-fill composite, and a conventional bulk-fill composite. Restorations will be clinically assessed at baseline, 1 month, 6 months, and 12 months for esthetic, functional, and biological outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled clinical follow-up study is planned to evaluate the clinical performance of posterior restorations performed with five different bulk-fill composite materials representing distinct technological approaches. The materials to be investigated include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER based bulk-fill composite, and a conventional bulk-fill composite.

The study will be conducted in patients requiring direct posterior restorations. After cavity preparation and restorative procedures performed according to the manufacturers' instructions, restorations will be placed using the assigned bulk-fill composite material. Clinical evaluations will be performed according to the World Dental Federation (FDI) criteria. The restorations will be assessed in terms of esthetic, functional, and biological properties.

Follow-up examinations will be carried out at baseline, 1 month, 6 months, and 12 months. The primary aim of the study is to compare the short-term clinical performance of bulk-fill composite materials with different technological characteristics. The findings are expected to provide clinically relevant information regarding the effectiveness and reliability of these restorative materials in posterior teeth.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Erzurum, Turkey (Türkiye), 25240
        • Atatürk University Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Cemile Arslan, Research Assistant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18 years and older
  • Patients in good general health (systemically healthy)
  • Patients with good oral hygiene
  • Patients with good periodontal health
  • Presence of at least one posterior tooth requiring restoration
  • Teeth must be vital and asymptomatic
  • Teeth must have proximal contact with adjacent teeth on both mesial and distal surfaces
  • Teeth must be in functional occlusion with an antagonist tooth
  • Presence of at least one carious lesion not extending deeper than two-thirds of dentin, with a clinical ICDAS code ≤ 3
  • Absence of periapical pathology confirmed by radiographic evaluation
  • Patients who voluntarily agree to participate and provide written informed consent

Exclusion Criteria:

  • Presence of any systemic disease
  • Poor oral hygiene
  • Presence of active or severe periodontal disease
  • Teeth with previous restorations or endodontic treatment
  • Non-vital (devitalized) or symptomatic teeth
  • Patients who are pregnant or breastfeeding
  • Patients undergoing active orthodontic treatment
  • Presence of parafunctional habits (e.g., bruxism) or xerostomia
  • Current tobacco use or history of heavy smoking
  • Patients unwilling or unable to attend follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Viscolor
Participants assigned to this group will receive posterior restorations using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions.
Other: Thermoviscous bulk-fill composite restoration
Posterior restorations in this group will be performed using a thermoviscous bulk-fill composite material applied after preheating according to the manufacturer's instructions.
Experimental: SonicFill
Participants assigned to this group will receive posterior restorations using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions.
Other: Sonic-activated bulk-fill composite restoration
Posterior restorations in this group will be performed using a sonic-activated bulk-fill composite material with reduced viscosity during placement, according to the manufacturer's instructions.
Experimental: Estelite Bulk Flow
Participants assigned to this group will receive posterior restorations using a flowable bulk-fill composite material applied according to the manufacturer's instructions.
Other: Flowable bulk-fill composite restoration
Posterior restorations in this group will be performed using a flowable bulk-fill composite material according to the manufacturer's instructions.
Experimental: Admira Fusion Xtra
Participants assigned to this group will receive posterior restorations using an ORMOCER-based bulk-fill composite material applied according to the manufacturer's instructions.
Other: ORMOCER-based bulk-fill composite restoration
Posterior restorations in this group will be performed using an ORMOCER-based bulk-fill composite material according to the manufacturer's instructions.
Experimental: Filltek Bulkfill Composite
Participants assigned to this group will receive posterior restorations using a conventional bulk-fill composite material applied according to the manufacturer's instructions.
Other: Conventional bulk-fill composite restoration
Posterior restorations in this group will be performed using a conventional bulk-fill composite material according to the manufacturer's instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance according to FDI criteria
Time Frame: Baseline (1 month), 6 months, and 12 months
The clinical performance of posterior restorations will be evaluated according to World Dental Federation (FDI) criteria, including esthetic, functional, and biological properties.
Baseline (1 month), 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Collaborators

Atatürk University Scientific Research Projects Coordination Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

June 20, 2027

Study Completion (Estimated)

July 20, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TDH-2026-17149 (Other Grant/Funding Number: Atatürk University Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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